Hepatocellular carcinoma less than 3 cm treated with percutaneous tumour destruction: multicentric phase 2 trial assessing the impact of idarubicin-lipiodol intra-arterial chemotherapy on hepatic recurrence.
- Conditions
- The research hypothesis is that hepatic locoregional treatment with idarubicin and lipiodol would be an effective adjuvant therapy of hepatocellular carcinomaTherapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2019-001362-15-FR
- Lead Sponsor
- niversity Hospital of Montpellier
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 138
- Age = 18 years and = 80 years
- Hepatopathy either histologically proven F3 or F4 stage, or with liver hardness measurements =10 kPa, either with suggestive morphological signs cirrhosis or portal hypertension viewed by medical Imaging
- Child-Pugh score =B7
- Patients with these biological parameters :
• platelets > 50 000/mm3
• neutrophils > 1000/mm3
• TP > 50%
• creatininemia < 150 µmol/L
• total bilirubinemia < 5 mg/dL
• a-fetoprotein < 200 ng/mL
- WHO 0 or 1
- unique and less than 3 cm hepatocellular carcinoma, with typical imaging characteristics as recommended by AASLD
- patient with an indication of percutaneous tumoral destruction (radio frequency or microwave) under ultrasound or CT scan
- Absence of heart failure (Left ventricular ejection fraction > 50%)
- Woman of childbearing age using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
- Man using a method of contraception for the duration of treatment and at least 3 months after the end of treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
- Pregnancy (determination of positive ßHCG) or breastfeeding according to article L1121-5 of the CSP.
- Presence on the initial imaging result of a macroscopic vascular invasion (portal or superhepatic vein).
- Presence on the initial imaging result of non-hepatic locations of hepatocellular carcinoma.
- Other non treated cancer
- Contraindication to general anaesthesia
- Contraindication to MRI Exploration
- Hypersensitivity to anthracyclines, iodine or gadolinium.
- Contraindication to injection of gadolinium-based contrast media
- Contraindication to injection of iodine-based contrast media
- Contraindication to idarubicin
- Contraindication to Lipiodol
- Patients who have already received or exceeded the recommended cumulative dose for anthracyclines (idarubicin = 150 mg/m²).
- Failure of endoscopic elimination of esophageal varices with level >1.
- Inability to accede to the protocol
- Patient who for psychological, social, family or geographical reasons could not be followed regularly
- Vulnerable persons according to Article L1121-6 of the CSP
- Concurrent patient participation in another research involving the human person.
- Non-affiliation with or no beneficiary of a social security scheme (Article L.1121-11).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method